Related Summaries

The FDA named members of a 14-member panel set up to advise the agency on scientific, technical and medical issues related to drug compounding. The panel includes physicians, pharmacists and regulatory experts.

Clinical Specialties Compounding recalled all the sterile products it has distributed in the country since Oct. 19, and the FDA warned health care providers following reports of serious eye infections tied to injections of the cancer treatment Avastin that had been prepared by the Georgia pharmacy. The FDA said the recall was extended to all of the company's other sterile products due to concerns about a lack of sterility assurance and covers dozens of treatments, including many eye treatments and antibiotics.

State scrutiny of specialty pharmacies is increasing in response to last fall's deadly meningitis outbreak tied to tainted steroids from the New England Compounding Center. States are considering making pharmacies get special permits to mix sterile drugs, and surprise inspections are being conducted. Virginia and Maryland are among a dozen states considering tighter licensing requirements. New York regulators issued a sales moratorium for one of the nation's biggest compounders, while Iowa's pharmacy board hopes to inspect more than 600 out-of-state compounders that supply medicines to the state.

Elekta has announced the release of its Versa HD system, an advanced linear accelerator with high-precision tumor-targeting and beam-shaping capabilities. The device is intended to provide specialized treatments that call for tumor-targeting precision, as well as traditional therapies for various tumors in all areas of the body.

Republicans on the House Energy and Commerce Committee could issue a subpoena if the FDA fails to produce by Feb. 25 key internal memos regarding the meningitis outbreak tied to the New England Compounding Center. "FDA has produced no communications from staff and officials at FDA headquarters, who were actually making the decisions about how to address the situation," committee chairman Fred Upton, R-Mich., and four other Republicans wrote in a letter to the agency. FDA spokeswoman Erica Jefferson said the agency had provided more than 3,500 pages and is preparing on a response to the panel.